Distraction devices and method of assembling the same

ABSTRACT

A method of assembling a system for manipulating the skeletal system includes obtaining a monolithic member having opposing ends, one end including a housing having an axially extending cavity. A distraction rod is obtained that has opposing ends, a first end having an inner threaded cavity. A rotatable, radially poled magnet is rotationally coupled to a lead screw having threads. The threads of the lead screw are engaged with the threaded cavity of the distraction rod. The magnet and at least a portion of the first end of the distraction rod are inserted into the axially extending cavity such that the distraction rod and the monolithic member are in coaxial relation to one another. The magnet is axially locked in relation to the monolithic member, wherein the axially locked magnet is capable of rotation. The distraction rod is rotationally locked in relation to the monolithic member.

FIELD OF THE INVENTION

The field of the invention generally relates to medical devices fortreating disorders of the skeletal system.

BACKGROUND

Distraction osteogenesis is a technique which has been used to grow newbone in patients with a variety of defects. For example, limblengthening is a technique in which the length of a bone (for example afemur or tibia) may be increased. By creating a corticotomy, orosteotomy, in the bone, which is a cut through the bone, the tworesulting sections of bone may be moved apart at a particular rate, suchas one (1.0) mm per day, allowing new bone to regenerate between the twosections as they move apart. This technique of limb lengthening is usedin cases where one limb is longer than the other, such as in a patientwhose prior bone break did not heal correctly, or in a patient whosegrowth plate was diseased or damaged prior to maturity. In somepatients, stature lengthening is desired, and is achieved by lengtheningboth femurs and/or both tibia to increase the patient's height.

Bone transport is a similar procedure, in that it makes use ofosteogenesis, but instead of increasing the distance between the ends ofa bone, bone transport fills in missing bone in between. There areseveral reasons why significant amounts of bone may be missing. Forexample, a prior non-union of bone, such as that from a fracture, mayhave become infected, and the infected section may need to be removed.Segmental defects may be present, the defects often occurring fromsevere trauma when large portions of bone are severely damaged. Othertypes of bone infections or osteosarcoma may be other reasons for alarge piece of bone that must be removed or is missing.

Intramedullary distraction devices and bone transport devices have beendevised which can be adjusted non-invasively, using a variety ofmechanisms such as magnets, motors, shape memory metals, and hydraulics.These devices are typically cylindrical and have a coaxially arranged,telescopic arrangement, in order to be low profile and allow forplacement within the medullary canal of the bone. In these devices, thelengthening mechanism is typically assembled inside a housing, and thenheld in place by welds, for example, circumferential or axial welds.Welds may be created by laser, electron beam, or several othertechnologies. Depending on the design, the weld may need to withstand alarge amount of stress, for a large number of cycles, and may also needto provide a hermetic seal when the device is implanted in the body of asubject. Typically, the strength of these devices is significantly belowa typical solid or tubular trauma nail that is placed intramedullary inthe canal of a broken bone. Because of this, patients withintramedullary distraction or bone transport devices must often usecrutches and refrain from full walking for several months, in order tominimize the possibility of breakage of their implants.

In addition to intramedullary distraction and bone transport devices,other types of distraction devices are used in orthopedic applications.Examples include spinal distraction devices for treating scoliosis andother spinal deformities, mandible distraction devices for lengtheningthe jaw in patient with severe micrognathia and other extramedullarydevices (attached to external portions of the bone to be lengthened orcontoured). Because these devices are also subjected to high stressesand large numbers of cycles, the welds used to construct their housingsare also challenged.

Non-invasively adjustable devices for spinal distraction are implantedin a surgical procedure, and then are non-invasively adjusted (e.g.lengthened) at regular intervals, such as monthly or quarterly. It istypical that an X-ray image is taken before and after the lengtheningprocedure, in order to visualize and confirm the amount of lengtheningthat has been achieved. If monthly lengthenings are performed, and ifimages are taken both before and after the lengthening, then at least 24x-ray images will be taken of that patient in one year. Some surgeonsfeel that only one image per lengthening procedure (for example, onlyafter the lengthening) is needed, and others feel it might be done evenless often. However, more information about the status of thelengthening of the implant is still desirable.

SUMMARY

In one embodiment, a method of assembling a system for manipulating theskeletal system includes obtaining a monolithic member having opposingends, one end including a housing having an axially extending cavity. Adistraction rod is obtained that has opposing ends, a first end havingan inner threaded cavity. A rotatable, radially poled magnet isrotationally coupled to a lead screw having threads. The threads of thelead screw are engaged with the threaded cavity of the distraction rod.The magnet and at least a portion of the first end of the distractionrod are inserted into the axially extending cavity such that thedistraction rod and the monolithic member are in coaxial relation to oneanother. The magnet is axially locked in relation to the monolithicmember, wherein the axially locked magnet is capable of rotation. Thedistraction rod is rotationally locked in relation to the monolithicmember.

In another embodiment, a method of assembling a system for manipulatingthe skeletal system includes obtaining a monolithic member havingopposing ends, one end including a housing having an axially extendingcavity. A distraction rod is obtained that has opposing ends, a firstend having an inner threaded cavity. A maintenance member formagnetically attracting at least one pole of a rotatable, radially poledmagnet is secured to the monolithic member. The rotatable, radiallypoled magnet is rotationally coupled to a lead screw having threads. Thethreads of the lead screw are engaged with the threaded cavity of thedistraction rod. The magnet and at least a portion of the first end ofthe distraction rod are inserted into the axially extending cavity suchthat the distraction rod and the monolithic member are in coaxialrelation to one another. The magnet is axially locked in relation to themonolithic member, wherein the axially locked magnet is capable ofrotation.

In another embodiment, a lengthening device for ultrasonic lengthmeasurement includes an elongate metallic member having a havingopposing ends, one end including an axially extending cavity, theelongate metallic member having a first landmark which is identifiableby ultrasound when the lengthening device is implanted along theskeletal system the subject. The lengthening device further includes adistraction rod having opposing ends and having a second landmark whichcreates a distinct ultrasonic signature, different from that of thedistraction rod, and which is identifiable by ultrasound when thelengthening device is implanted along the skeletal system the subject,wherein a particular amount of axial movement of the distraction rod inrelation to the metallic member causes an equal change in the distancebetween the first landmark and the second landmark.

In another embodiment, a method for measuring a distraction length of alengthening device using ultrasound includes implanting the lengtheningdevice within a subject, the lengthening device having an elongatemetallic member having opposing ends, one end including an axiallyextending cavity, the elongate metallic member also having a firstlandmark which is identifiable by ultrasound when the lengthening deviceis implanted along the skeletal system the subject, the lengtheningdevice further including a distraction rod having opposing ends andhaving a second landmark which creates a distinct ultrasonic signature,different from that of the distraction rod, and which is identifiable byultrasound when the lengthening device is implanted along the skeletalsystem the subject. An ultrasonic probe is placed adjacent the skin ofthe subject in the vicinity of the first landmark and the secondlandmark. An ultrasonic image of at least the first landmark and thesecond landmark is obtained. The actual length between the firstlandmark and the second landmark is determined based at least in part onthe ultrasonic image.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a spinal distraction device having a monolithic rodand housing.

FIG. 2 illustrates the same spinal distraction device in a side view.

FIG. 3 illustrates a sectional view of the spinal distraction device ofFIG. 2 along line 3-3.

FIG. 4 illustrates a cross-sectional view of the spinal distractiondevice of FIG. 2 along line 4-4.

FIG. 5 illustrates detailed view 5 of FIG. 3.

FIG. 6 illustrates detailed view 6 of FIG. 3.

FIG. 7 illustrates detailed view 7 of FIG. 3.

FIG. 8 illustrates detailed view 8 of FIG. 3.

FIG. 9A illustrates a distraction rod of the spinal distraction deviceof FIGS. 1-8 having ultrasound scattering marks.

FIG. 9B illustrates a first alternative embodiment for ultrasoundscattering.

FIG. 9C illustrates a second alternative embodiment for ultrasoundscattering.

FIG. 9D illustrates a third alternative embodiment for ultrasoundscattering.

FIG. 9E illustrates detail 9E of the third alternative embodiment forultrasound scattering of FIG. 9D.

FIG. 10 illustrates a device and method for measuring the amount ofdistraction length in a spinal distraction device, using only ultrasoundimaging.

FIG. 11 is an ultrasound image of a spinal distraction device for thepurpose of measuring the amount of distraction length.

FIG. 12 illustrates an intramedullary limb lengthening device having amonolithic rod and housing.

FIG. 13 illustrates the same intramedullary limb lengthening device in aside view.

FIG. 14 illustrates a sectional view of the intramedullary limblengthening device of FIG. 13 along line 14-14.

FIG. 15A illustrates detailed view 15 of FIG. 14.

FIG. 15B illustrates a sectional view of an alternative embodiment of anintramedullary limb lengthening device.

FIG. 15C illustrates a ring gear insert of the embodiment of FIG. 15B.

FIG. 15D illustrates a coupling assembly of the embodiment of FIG. 15B.

FIG. 16 illustrates an exploded view of the intramedullary limblengthening device of FIGS. 12 through 15A.

FIG. 17 illustrates detailed view 17 of FIG. 16.

FIG. 18 illustrates internal components of an external adjustment devicefor non-invasively adjusting an intramedullary limb lengthening deviceaccording to one embodiment.

FIG. 19 illustrates an external adjustment device in a configuration foradjusting an intramedullary limb lengthening device implanted within thefemur.

FIG. 20 illustrates a process for assembling a spinal distraction devicehaving improved strength.

FIG. 21 illustrates a process for assembling an intramedullary limblengthening device having improved strength.

FIG. 22 illustrates a distraction rod and magnetic assembly beinginserted into the monolithic member of the spinal distraction device.

FIG. 23 illustrates an assembly being inserted into the monolithicmember of the intramedullary limb lengthening device.

FIG. 24 illustrates the assembly of FIG. 23 being pushed further intothe monolithic member with a cannulated tool.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

FIGS. 1 and 2 illustrate a spinal distraction device 100 comprising adistraction rod 102 and a monolithic member 104. The monolithic member104 extends between a first end 110 and a second end 112, and includes ahollow housing 106 and a solid segment 108, as better appreciated in thesectional view of FIG. 3. The monolithic member 104 is formed as aunitary structure with no seams or joints. The distraction rod 102 alsoincludes a solid segment 114 and a hollow segment 116. Like themonolithic member 104, the distraction rod 102 is a unitary structurewith no seams or joints connecting various sub-components. Both thedistraction rod 102 and the monolithic member 104 may be made from avariety of biocompatible materials, including titanium, Titanium-6Al-4V,cobalt chromium alloys, and stainless steel. Because the distraction rod102 and the monolithic member 104 are the primary load bearing membersof the spinal distraction device 100, and because neither has anyexternal circumferential weld, the spinal distraction device 100 iscapable of withstanding improved loading challenges in comparison tostandard spinal distraction devices. The solid segment 108 of themonolithic member 104 and the solid segment 114 of the distraction rod102 have over a majority of their lengths respective diameters orthicknesses that provide a range between about 2.5 mm to about 7.5 mm,and more commonly between about 4.5 mm to about 6.35 mm. These solidsegments 108, 114 are configured to allow coupling to pedicle screws andhooks, used for attachment to portions of the vertebrae. They may alsohave non-circular cross-sections, and in those cases compatible withother types of pedicle screws and hooks.

The respective cross-sectional views in FIG. 4 and FIGS. 5 through 8show more detail of the spinal distraction device 100 in combinationwith FIGS. 1 through 3. A magnet 138 is a cylindrical, radially-poledrare earth magnet, for example of neodymium-iron-boron. The magnet 138is enclosed and bonded within a magnet housing 140, which in turn isrotatably contained between a thrust bearing 142 and a radial bearing144. The magnet 138 may be bonded within the magnet housing 140 byepoxy. The magnet housing 140 is coupled to a lead screw 134 by a pin146 and a coupler 148. The coupler 148 is welded to an end 150 of themagnet housing 140 and both the coupler 148 and the lead screw 134 haveholes through which the pin 146 is placed. The thrust bearing 142 isheld over a centering pin 154, which fits into a cavity 158 at an end ofthe hollow housing 106 of the monolithic member 104. A radial bearing144 is held within a spacer ring 156. The distraction rod 102 has afirst end 118 and a second end 120 and is configured to betelescopically expandable from the hollow housing 106 of the monolithicmember 104. A nut 132 is bonded within a cavity 152 of the hollowsection 116 of the distraction rod 102, and the lead screw 134 engagesthe nut 132, so that rotation of the lead screw 134 in a first directiondistracts or lengthens the distraction rod 102 and rotation of the leadscrew 134 in a second, opposite direction retracts or shortens thedistraction rod 102. Two grooves 122 run in an axial direction along theouter wall of the distraction rod 102, from a first end 126 (FIG. 2) toa second end 128 (FIG. 6). Pins 124 are spot welded or attached by othermeans to the wall of the hollow housing 106 of the monolithic member104. The pins 124 extend radially into the grooves 122, thus assuringthat the distraction rod 102 may not rotate in relation to themonolithic member 104, while also allowing axial extension andretraction of the distraction rod 102 in relation to the monolithicmember 104. When the distraction rod 102 is fully retracted, a leadingedge 130 of the pin 124 abuts the first end 126 of the groove 122,keeping any further retraction from happening, and avoiding any jammingbetween the nut 132 and the lead screw 134. When the distraction rod 102is fully distracted, a leading edge 136 of the pin 124 abuts a secondend 128 of the groove 122, thus assuring that the distraction rod 102remains at least partially within the hollow housing 106 of themonolithic member 104.

Turning to FIG. 4, the magnet 138, comprising a north pole 160 and asouth pole 162 is shown as bonded within the magnet housing 140 insidethe hollow housing 106 of the monolithic member 104. Two maintenancemembers 164 are secured to the inner wall of the hollow housing 106 ofthe monolithic member 104 about 180° from each other alongcircumference. As shown, maintenance members 164 are curved plates,preferably made from a material such as 400 series stainless steel,which has magnetic properties that allow attraction to the poles 160,162 of the magnet 138 when closely located. This aligns the magnet 138,as shown, and as the subject moves, the magnet 138 is not allowed toturn, but rather stays in the desired orientation. When distracting thespinal distraction device 100 with a strong external, moving magneticfield, however, the attraction of the magnet 138 to the maintenancemembers 164 is overcome easily, allowing the magnet 138 to turn. Themaintenance members 164 may be resistance welded or adhesive or epoxybonded to the inner wall of the monolithic member 104. Alternatively,only one maintenance member 164 may be used, allowing attraction toeither pole 160 or pole 162 of the magnet 138, but still aligning themagnet 138. In applications where patient movement is not significant,it may not be necessary to include any maintenance members 164.

The method for assembling the spinal distraction device 100 isillustrated in FIG. 20. In operation 500, the distraction rod 102 andthe monolithic member 104 are individually manufactured, for example bymachining processes incorporating manual or automated lathes. Includedwithin this manufacturing operation may be the forming of anaxially-extending cavity within the monolithic member 104.Post-processing may be included in this operation, for example beadblasting, passivation or anodizing. In operation 502, the distractionrod 102 and the monolithic member 104 are prepared for mating. In thisoperation, the nut 132 is bonded into the distraction rod 102. One ormore o-rings 168 are placed in circumferential cavities 170 of thedistraction rod 102. One or more maintenance members 164 are bonded inplace. A centering pin 154 is placed into the cavity 158 at the end ofthe hollow housing 106 of the monolithic member 104. The centering pin154 may be press fit into the cavity 158, or may be bonded with anadhesive, epoxy or other joining means. The thrust bearing 142 is placedover the centering pin 154. In operation 504, the distraction rod 102 iscoupled to the magnet 138. In this operation, the magnet 138 is bondedinto the magnet housing 140. The magnet housing 140 may be a two pieceassembly, for example a clamshell configuration, or bookends, or acup/cap configuration. The radial bearing 144 is pressed over the end150 of the magnet housing 140 and the coupler 148 is welded or bonded tothe end 150 of the magnet housing 140. The lead screw 134 is attached tothe coupler 148 by the placing the pin 146 through the holes in thecoupler 148 and the lead screw 134. The spacer ring 156 is then slidinto place over the coupler 148 and the radial bearing 144. The leadscrew 134 is screwed into the nut 132. In operation 506, the distractionrod 102 and magnet assembly 131 as seen in FIG. 22 (including magnet138/magnet housing 140/radial bearing 144/coupler 148/lead screw 134/pin146/spacer ring 156/nut 132/distraction rod 102) are then inserted intothe hollow housing 106 of the monolithic member 104 (see FIG. 22). Inoperation 508, the magnet assembly 131 is axially locked in place withinthe hollow housing 106 of the monolithic member 104. More specifically,a sleeve 166 having an outer diameter close to the inner diameter of thehollow housing 106 of the monolithic member 104 is pushed into thehollow housing 106 and either press fit or bonded in place. It may alsobe resistance welded in place. The sleeve 166 serves to push theassembled items into their desired axial location. When the sleeve 166is bonded, it then holds the components in this configuration. The twodifferent inner diameter portions of the spacer ring 156 have theappropriate diameters and lengths so that the spacer ring 156 does notcontact the magnet housing 140. In operation 510, the distraction rod isrotationally locked in relation to the monolithic member. The sleeve 166is supplied with holes to match those in the wall of the hollow housing106 through which the pins 124 are placed. Alternatively, holes may bedrilled through the sleeve 166 using the holes in the hollow housing 106as a guide. The o-rings 168 of the distraction rod 102 serve to sealbetween the distraction rod 102 and the inner diameter of the sleeve166. The outer diameter of the sleeve 166 is sealably attached to theinner diameter of the hollow housing 106 via the adhesive or epoxy withwhich it is attached. Together, these two seals protect the innercontents of the hollow housing 106 of the monolithic member 104 frombody fluids.

FIG. 9A is a view of the distraction rod 102 of the spinal distractiondevice 100 of FIG. 1, having a tapered portion 101, and showing fourlandmarks 172, 174, 176, 178 for scattering ultrasound. The landmarksmay consist of drilled indentations or partial holes, for exampledrilled with a small end mill. Typical hole diameter is about 1.00 mm,and typical hole depth is about 0.75 mm. In this embodiment, thedistraction rod 102 is formed of a metal, for example Titanium 6AL-4V,and thus is very reflective of ultrasound waves, and because of itscontinuity and smooth surface, a consistent bright line will be seen(see white contour of distraction rod 102 image in FIG. 11). Thelandmarks 172, 174, 176, 178, for example made with the holes described,serve to break up this continuity, and give a small, but recognizablepattern in an ultrasound image. By using a different number of holes, ora varying array of holes, different image characteristics can beachieved. For example, landmark 172 is a single hole, while landmark 174is a (in this figure) vertically arrayed pair of holes, with a distanceof 1.50 mm from center to center. Landmark 176 consists of threevertically arrayed holes, with a center-to-center distance of adjacentholes of 1.25 mm. Landmark 178 is two diagonally arrayed holes with acenter-to-center distance of 2.75 mm.

FIG. 10 illustrates the spinal distraction device 100 implanted in asubject, and attached to four vertebrae 184 using pedicle screws 182.The spinal distraction device 100 has been lengthened a cumulative totalamount of 17.6 mm, and landmarks 172, 174 have been extended from thehollow housing 106 of the monolithic member 104, while landmarks 176,178 are still inside. The nose 188 of an ultrasound probe 186 is coatedwith an ultrasound gel and pressed over the skin 190. The ultrasoundprobe 186 illustrated has a linear array transducer 192 having a span of40 mm, though probes are also available with spans of up to 64 mm, suchas the General Electric L764. Typically, a transducer capable of beingrun at five to ten MegaHertz (5.0-10.0 MHz) is appropriate for thespinal distraction application, because it will be able to image thespinal distraction device 100 at its typical range of depths, based onpatient tissue thickness. As seen in FIG. 10, the ultrasound probe 186is centered over the region of interest (ROI), and adjusted until animage such as that in FIG. 11 can be visualized. The region of interestin FIG. 10 includes the extended landmarks 172, 174 and the first end110 of the monolithic member 104. A cable 202 transfers signals back andforth between the linear array transducer 192 and an ultrasound unit200. Signals are processed in a processor 206, and can be stored in amemory 208. An interface (keyboard, touch screen, etc.) 210 can bemanipulated by the user to operate the ultrasound unit 200. Theresulting image may be visualized on a display 204. Ultrasound waves 212are transmitted to the spinal distraction device 100 and reflected waves214 are received. In a subject 180 with a large amount of fat 194 or onein which the spinal distraction device 100 has been implantedsignificantly below the muscle 196, it is possible to hold the handle198 of the ultrasound probe 186 and compress the fat 194, to bring thelinear array transducer 192 of the ultrasound probe 186 closer to thespinal distraction device 100, as seen in FIG. 10. This assures that thedesired image is located well within the display of the ultrasound unit200.

In FIG. 11, an ultrasound scan 216 was performed using a 40 mm lineararray transducer at 8.0 MHz. Skin 190, fat 194, and muscle 196 coveredby fascia 218 can be clearly seen, as can the surface of the distractionrod 102, seen in bright white, and the first end 110 of the monolithicmember 104. Beneath these features is an area of ultrasonic shadowing220, due to lack of penetration of the ultrasound wave past the highlyreflective titanium of the distraction rod 102 and the monolithic member104. A first landmark 222 and second landmark 224 are also visible onthe ultrasound scan 216. Because the distraction rod 102 and themonolithic member 104 move relative to each other when the spinaldistraction device 100 is lengthened or shortened, a measurement shouldbe taken between a landmark on the distraction rod 102 and a landmark onthe monolithic member 104. The preferred landmark on the monolithicmember 104 is the first end 110, because it is easy to appreciate thedrop off in diameter from it to the distraction rod 102 that is seenextending from the monolithic member 104. The user placed a first cursor226 along the x-axis in line with the first end 110, but on the y-axisat the level of the surface of the distraction rod 102. Varying they-axis location is not necessary in ultrasound units that give an xdistance, y distance and a hypotenuse. A second cursor 228 was thenmoved to the desired landmark on the distraction rod 102, for examplelandmark 222 or landmark 224. Many ultrasound units allow for accurateon-screen caliper measurements, but alternatively, the distance betweenfirst landmark 222 and second landmark 224, a known, controlleddistance, may be used for accurate scaling.

The holes depicted in FIG. 9A may be left open, or they may be filled,for example with epoxy. The epoxy may be doped with ceramic particles,in order to scatter the ultrasound in a still different manner. As analternative to the landmarks 172, 174, 176, 178 described in FIG. 9A,several alternative embodiments for scattering ultrasound are presentedin FIGS. 9B through 9D, particularly depicting tapered portion 101 ofdistraction rod 102. The tapered portion 101 includes a taper 107 thatextends between small diameter segment 103 and large diameter segment105. Large diameter segment 105 has a typical diameter of about 6.35 mmand small diameter segment 103 has a typical diameter of about 2.5 to6.0 mm, or more particularly 4.5 mm to 6.0 mm. Between the smalldiameter segment 103 and that taper 107 is a radiused transition. InFIG. 9B, a sharp transition 111 is formed in the distraction rod 102 atthe tapered portion 101. This sharp transition 111 provides a highlydefined point in the ultrasound image for making a precision axialmeasurement. In FIG. 9C, an embodiment is depicted which features ashort ridge 113 extending around the distraction rod 102. The ridge 113also provides a highly defined point for resolving in an ultrasoundimage. FIG. 9D depicts an embodiment having an ultrasound focusingfeature 115 in place of the ridge 113 of FIG. 9C. The ultrasoundfocusing feature 115, as seen in more detail in FIG. 9E, includes aconcave radius 117 extending around the distraction rod 102. Ultrasoundreflects at a range of angles along different axial points on theconcave radius 117, and the reflected ultrasound from these variousreflections meets at a focal point 119, thus creating a recognizableimage.

FIGS. 12 and 13 illustrate an intramedullary limb lengthening device 300comprising a distraction rod 302 and a monolithic member 304. Themonolithic member 304 extends between a first end 310 and a second end312, as better appreciated in the sectional view of FIG. 14. Themonolithic member 304 is formed as a unitary structure with no seams orjoints. The distraction rod 302 has a first end 318 and a second end320, and is configured to be telescopically extendable and retractablewithin the monolithic member 304. Like the monolithic member 304, thedistraction rod 302 is a unitary structure with no seams or jointsconnecting various sub-components. Both the distraction rod 302 and themonolithic member 304 may be made from a variety of biocompatiblematerials, including titanium, for example Titanium-6AL-4V, cobaltchromium alloys, and stainless steel. Because the distraction rod 302and the monolithic member 304 are the primary load bearing members ofthe intramedullary limb lengthening device 300, and because neither hasany external circumferential weld, the intramedullary limb lengtheningdevice 300 is capable of withstanding improved loading challenges incomparison to standard intramedullary limb lengthening devices. Themonolithic member 304 contains two transverse holes 301 for passing bonescrews, with which to attach the intramedullary limb lengthening device300 to the bone. The distraction rod 302 contains three transverse holes303, also for the passing of bone screws. At the second end 312 of themonolithic member 304, a coupling feature 323, provides an interface toreleasably engage with an insertion instrument, such as a drill guide.The drill guide may include a male thread and the coupling feature 323may be provided with a complementary female thread. The intramedullarylimb lengthening device 300 comprises a magnet 338 which is bondedwithin a magnet housing 340 and configured for rotation between a radialbearing 344 and a thrust bearing 342. Between the thrust bearing 342 andthe magnet housing 340 are three planetary gear stages 305, 307, 309, asseen in FIG. 15A. The planetary gear stages 305, 307, 309 each comprisea sun gear 311A, 311B, 311C and three planetary gears 313, which arerotatably held within a frame 315 by pins 317. The sun gear 311 iseither a part of the magnet housing 340, as in the case of the sun gear311A of planetary gear stage 305, or a part of the frame 315, as in sungear 311B or gear stage 307 and sun gear 311C of gear stage 309. Therotation of the sun gear 311 causes the planetary gears 313 to rotateand track along inner teeth 321 of a ring gear insert 319. Each gearstage 305, 307, 309 has a gear reduction of 4:1, with a total gearreduction of 64:1.

The frame 315 of the final gear stage 309 passes through the thrustbearing 342 and is attached to a lead screw coupler 366 such thatrotation of the frame 315 of the final gear stage 309 causes one-to-onerotation of the lead screw coupler 366. The lead screw coupler 366 and alead screw 358 each contain transverse holes through which a locking pin368 is placed, thus rotationally coupling the lead screw 358 to thefinal gear stage 309. A locking pin retainer 350 is slid over and tackwelded to the lead screw coupler 366 to radially maintain the lockingpin 368 in place. The distraction rod 302 has an internally threaded end363, into which external threads 365 of a nut 360 are threaded andbonded, for example with epoxy. The nut 360 has internal threads 367which are configured to threadably engage with external threads 325 ofthe lead screw 358, thereby allowing rotation of the lead screw 358 todistract the distraction rod 302 in relation to the monolithic member304. Rotation of the magnet 338 and the magnet housing 340 causesrotation of the lead screw at 1/64 the rotational speed, but withsignificantly increased torque (64 times, minus frictional losses), andthus an amplified distraction force. O-rings 362 are placed in ringgrooves 388 on exterior of the distraction rod 302 and create a dynamicseal between the monolithic member 304 and the distraction rod 302, thusprotecting the internal contents from body fluids. A split washer stop364, located between the distraction rod 302 and the lead screw coupler366, guards against jamming that would otherwise be caused as thedistraction rod 302 approaches the lead screw coupler 366, for exampleif intramedullary limb lengthening device 300 is fully retracted with ahigh torque applied by an external moving magnetic field.

A maintenance member 346, comprising a curved plate made from 400 seriesstainless steel, is bonded within the inner wall of the monolithicmember 304 by epoxy, adhesive, resistance welding or other suitableprocess. The maintenance member 346 attracts a pole of the magnet 338,thus keeping the limb lengthening device 300 from being accidentallyadjusted by movements of the patient. However, a strong moving magneticfield, such as that applied by magnetic adjustment devices known in theart, is capable of overcoming the attraction of the magnet 338 to themaintenance member 346 in order to rotate the magnet 338 and adjust thelength of the intramedullary limb lengthening device 300. Maintenancemember has a thickness of approximately 0.015 inches and spans acircumferential arc of less than 180°. An exemplary arc is 99°.

The method for assembling the intramedullary limb lengthening device 300is illustrated in FIG. 21. These assembly operations and the design ofthe internal components make it possible to incorporate the monolithicmember 304 into the design of the intramedullary limb lengthening device300. In operation 600, the distraction rod 302 and the monolithic member304 are individually manufactured, for example by machining processesincorporating manual or automated lathes. Included within thismanufacturing operation may be the forming of an axially-extendingcavity within the monolithic member 304. Post-processing may be includedin this operation, for example bead blasting, passivation or anodizing.In operation 602, the distraction rod 302 and the monolithic member 304are prepared for mating. In this operation, the nut 360 is bonded intothe distraction rod 302 and the o-rings 362 are placed into the ringgrooves 388 as described. The maintenance member 346 is bonded to themonolithic member 304. In operation 604, the magnet 338 is placed intothe cavity 390 of the monolithic member 304. In this operation themagnet 338 and the magnet housing 340 are bonded together, and thenassembled with the radial bearing 344 into the monolithic member 304(see FIG. 14). Prior to assembling the radial bearing 344 into themonolithic member, the longitudinal depth of the cavity 390 of themonolithic member 304 is measured, and, if necessary, one or more shimsmay be placed before the radial bearing 344 so that the resultant axialplay in the assembled components is not so low as to cause binding, yetnot so high as to risk disassembly. In operation 606, the lead screw 358is prepared for coupling to the magnet 338 that is in the cavity 390 ofthe monolithic member 304. In this operation the ring gear insert 319 isslid into the cavity 390 of the monolithic member 304 until it abuts aledge 392. First and second planetary gear stages 305, 307 are thenplaced into assembly as seen in FIG. 15A. The locking pin retainer 350is preloaded over the lead screw coupler 366 prior to welding the leadscrew coupler 366 to the final planetary gear stage 309, and is thenslid in place over the locking pin 368 after the locking pin 368 isplaced. Final planetary gear stage 309 is inserted through the thrustbearing 342 and is welded to the lead screw coupler 366, allowing forsome axial play of the thrust bearing 342. The split washer stop 364 isthen placed onto the lead screw 358. The lead screw 358 is then attachedto the lead screw coupler 366 with the locking pin 368, and then thelocking pin retainer 350 is slid over a portion of the ends of thelocking pin 368 and tack welded to the lead screw coupler 366. Thrustbearing retainers 354, 356 are two matching pieces which form acylindrical clamshell around the thrust bearing 342 and the lead screwcoupler 366. The internal diameter of the monolithic member 304 istinned with solder, as are the outer half diameter surfaces of each ofthe thrust bearing retainers 354, 356. In operation 608, the thrustbearing retainers 354, 356 are then clamped over an assembly 327(illustrated in FIG. 23) containing the thrust bearing 342, lead screwcoupler 366, planetary gear stage 309, and lead screw 358, and thethrust bearing retainers 354, 356 and the assembly 327 are pushedtogether into place within the monolithic member with a cannulated tool329 (see FIGS. 23 and 24). The cannulated tool 329 has a chamfered end331 which pushes against a matching chamfer 352 in each of the thrustbearing retainers 354, 356, thus forcing them outward against the innerdiameter of the monolithic member 304. The sun gear 311C of the finalplanetary gear stage 309 engages with the planet gears 313 of the finalplanetary gear stage 309 and then chamfered edges 394 of the thrustbearing retainers 354, 356 are pushed against a chamfer 348 of the ringgear insert 319 with a pre-load force. In operation 610, the thrustbearing 342 and the magnet 338 are axially retained. In this operation,the thrust bearing retainers 354, 356 are soldered to the monolithicmember 304 at the tinned portions, thus maintaining the pre-load forcein place. This may be accomplished using induction heating. The frictionof the ledge 392 and the chamfered edge 394 against opposing ends of thering gear insert 319, as well as the wedging between the chamfered edge394 and the chamfer 348, hold the ring gear insert 319 rotationallystatic in relation to the monolithic member 304. Alternatively, the ringgear insert 319 may have a keyed feature that fits into a correspondingkeyed feature in the monolithic member 304, in order to stop the ringgear insert 319 from being able to turn in relation to the monolithicmember 304, in case the friction on the ends of the ring gear insert 319is not sufficient to hold it static.

In operation 612, the distraction rod 302 is engaged with the lead screw358. In this operation an assembly tool consisting of a high speedrotating magnet is used to make the magnet 338 and thus the lead screw358 rotate and the distraction rod 302 is inserted into the monolithicmember 304 while the lead screw 358 engages and displaces in relation tothe nut 360 of the distraction rod 302. After the distraction rod 302 isinserted into the monolithic member 304 as described and retracted atleast somewhat, the distraction rod 302 is still free to rotate inrelation to the monolithic member 304. For the stability of the bonepieces being distracted it is desired to inhibit rotation between thedistraction rod 302 and the monolithic member 304, and this finalportion of the assembly process is described in relation to FIGS. 16 and17. In operation 614, the distraction rod 302 is rotationally locked inrelation to the monolithic member 304. In this operation, ananti-rotation ring 370 is placed over the distraction rod 302 byengaging protrusions 374, one on each side, into grooves 372 extendingalong the distraction rod 302 and then by sliding the anti-rotation ring370 up to a tapered inner edge 376 of the monolithic member 304. Theanti-rotation ring 370 and the distraction rod 302 are then rotateduntil guide fins 382 can be inserted into guide cuts 380 in end of themonolithic member 304. The anti-rotation ring 370 is now axially snappedinto the monolithic member 304 as a flat edge 384 of the anti-rotationring 370 is trapped by an undercut 378. The undercut 378 has a minimumdiameter which is less than the outer diameter of the flat edge 384 ofthe anti-rotation ring 370, and is temporarily forced open during thesnapping process. As assembled, the anti-rotation ring 370, themonolithic member 304 and the distraction rod 302 are all heldrotationally static in relation to each other. In addition, when theintramedullary limb lengthening device 300 reaches maximum distractionlength, the ends 386 of grooves 372 abut the protrusions 374, and thusthe distraction rod 302 is kept from falling out of the monolithicmember 304.

An alternative embodiment of the intramedullary limb lengthening device300 of FIGS. 12-15A is shown in a sectional view in FIG. 15B. Much ofthis embodiment is identical to the embodiment of FIGS. 12-15A, howeverthe differences are hereby described. The embodiment does not havethrust bearing retainers 354, 356, but instead incorporates a thrustbearing ferrule 335 having an external tapered end 347. A thrust bearingretainer 337, a locking pin retainer 341 and the thrust bearing ferrule335 are placed over the thrust bearing 342 and a lead screw coupler 339,and the final planetary gear stage 309 is inserted through the thrustbearing 342 and is welded to the lead screw coupler 339. As shown inFIG. 15D, the locking pin retainer 341 has a relief 361 to allow thepassage of the locking pin 368. After the locking pin 368 is placed, thelocking pin retainer 341 is rotated so that the relief 361 is no longerdirectly over the locking pin 368 and the locking pin retainer 341 istack welded or secured by other methods to the lead screw coupler 339,thus retaining the locking pin 368. These assembled components are theninserted into the cavity 390 of the monolithic member 304, where thefinal planetary gear stage 309 is coupled to the other planetary gearstages 305, 307 and the magnet 338. In this embodiment, a ring gearinsert 333 (FIG. 15C) has an indentation 351 on each side. A tab 349 oneach side of the thrust bearing ferrule 335 inserts into eachindentation 351, in order to inhibit rotation of the ring gear insert333 in relation to the monolithic member 304, once the thrust bearingferrule 335 is engaged into the monolithic member 304. Also in thisembodiment, the monolithic member 304 contains internal threading 343.The engagement of the thrust bearing ferrule 335 is achieved bytightening external threading 345 of the thrust bearing retainer 337into the internal threading 343 of the monolithic member 304. A tool(not shown) is engaged into cut outs 357 on each side of the thrustbearing retainer 337 and is used to screw the thrust bearing retainer337 into the internal threading 343 of the monolithic member 304. Asshown in FIG. 15B, this wedges an internal taper 353 of the thrustbearing retainer 337 against the external tapered end 347 of the thrustbearing ferrule 335, allowing the thrust bearing ferrule 335 to apply acontrolled load on the ring gear insert 333, locking the ring gearinsert 333 axially and rotationally in relation to the monolithic member304. The thrust bearing retainer 337 contains an axial split on theopposite side (not shown). The split in the thrust bearing retainer 337,allows the outer diameter of the thrust bearing retainer 337 to beslightly reduced (by compression) while it is inserted into themonolithic member 304, prior to being threaded, so that the internalportion of the monolithic member 304 is not scratched during insertion.A ledge 355 is visible on the lead screw coupler 339 in FIG. 15D. Asnoted earlier, the split washer stop 364 butts up against this ledge 355to prohibit jamming when the distraction rod 302 is retractedcompletely.

FIGS. 18 and 19 illustrate an external adjustment device 478 configuredfor applying a moving magnetic field to allow for non-invasiveadjustment of the intramedullary limb lengthening device 300 by turningthe magnet 338 within the intramedullary limb lengthening device 300.FIG. 18 illustrates the internal components of the external adjustmentdevice 478, and for clear reference, shows the magnet 338 of theintramedullary limb lengthening device 300, without the rest of theassembly. The internal working components of the external adjustmentdevice 478 may, in certain embodiments, be similar to that described inU.S. Patent Application Publication No. 2012/0004494, which isincorporated by reference herein. A motor 480 with a gear box 482outputs to a motor gear 484. The motor gear 484 engages and turns acentral (idler) gear 486, which has the appropriate number of teeth toturn first and second magnet gears 488, 490 at identical rotationalspeeds. First and second magnets 492, 494 turn in unison with the firstand second magnet gears 488, 490, respectively. Each magnet 492, 494 isheld within a respective magnet cup 496 (shown partially). An exemplaryrotational speed is 60 RPM or less. This speed range may be desired inorder to limit the amount of current density induced in the body tissueand fluids, to meet international guidelines or standards. As seen inFIG. 18, the south pole 498 of the first magnet 492 is oriented the sameas the north pole 404 of the second magnet 494, and likewise, the firstmagnet 492 has its north pole 400 oriented the same as the south pole402 of the second magnet 494. As these two magnets 492, 494 turnsynchronously together, they apply a complementary and additive movingmagnetic field to the radially-poled, magnet 338, having a north pole406 and a south pole 408. Magnets having multiple north poles (forexample, two) and multiple south poles (for example, two) are alsocontemplated in each of the devices. As the two magnets 492, 494 turn ina first rotational direction 410 (e.g., counter-clockwise), the magneticcoupling causes the magnet 338 to turn in a second, opposite rotationaldirection 412 (e.g., clockwise). The rotational direction of the motor480 is controlled by buttons 414, 416. One or more circuit boards 418contain control circuitry for both sensing rotation of the magnets 492,494 and controlling the rotation of the magnets 492, 494.

FIG. 19 shows the external adjustment device 478 for use with anintramedullary limb lengthening device 300 placed in the femur. Theexternal adjustment device 478 has a first handle 424 attached to ahousing 444 for carrying or for steadying the external adjustment device478, for example, steadying it against an upper leg 420, as in FIG. 19,or against a lower leg 422 in the case that the intramedullary limblengthening device 300 is implanted in the tibia. An adjustable handle426 is rotationally attached to the external adjustment device 478 atpivot points 428, 430. The pivot points 428, 430 have easilylockable/unlockable mechanisms, such as a spring loaded brake, ratchetor tightening screw, so that a desired angulation of the adjustablehandle 426 in relation to the housing 444 can be adjusted and locked inorientation. The adjustable handle 426 is capable of being placed inmultiple positions. In FIG. 19, adjustable handle 426 is set so that theapex 432 of loop 434 rests against housing end 436. In this position,patient 438 is able to hold onto one or both of grips 440, 442 while theadjustment is taking place. Patient is able to clearly view a controlpanel 446 including a display 448. In a different configuration from thetwo directional buttons 414, 416 in FIG. 18, the control panel 446includes a start button 450, a stop button 452 and a mode button 454.Control circuitry contained on circuit boards 418 may be used by thesurgeon to store important information related to the specific aspectsof each particular patient. For example, in some patients an implant maybe placed antegrade into the tibia. In other patients the implant may beplaced either antegrade or retrograde into the femur. By having theability to store information of this sort that is specific to eachparticular patient within the external adjustment device 478, theexternal adjustment device 478 can be configured to direct the magnets492, 494 to turn in the correct direction automatically, while thepatient need only place the external adjustment device 478 at thedesired position, and push the start button 450. The information of themaximum allowable distraction length per day and per distraction sessioncan also be input and stored by the surgeon for safety purposes. Thesemay also be added via an SD card or USB device, or by wireless input. Anadditional feature is a camera at the portion of the external adjustmentdevice 478 that is placed over the skin. For example, the camera may belocated between the first magnet 492 and the second magnet 494. The skindirectly over the implanted magnet 338 may be marked with indelible ink.A live image from the camera is then displayed on the display 448 of thecontrol panel 446, allowing the user to place the first and secondmagnets 492, 494 directly over the area marked on the skin. Crosshairscan be overlayed on the display 448 over the live image, allowing theuser to align the mark on the skin between the crosshairs, and thusoptimally place the external adjustment device 478.

As described in conjunction with the spinal distraction device 100 ofFIGS. 1 through 8 and with the intramedullary limb lengthening device300 of FIGS. 12-17, load-bearing orthopedic devices can be constructedwhich, by incorporating a monolithic member 104, 304 having a unitarystructure with no seams or joints, have improved strength over prior artdevices having welded joints. Four point bend testing of monolithicmembers 304 constructed in accordance with the methods described hereinshowed that a strength improvement of 38% was achieved as compared todata obtained on elongate members which incorporated a housing having alaser weld. Additionally, the embodiments for the spinal distractiondevice 100 and the intramedullary limb lengthening device 300 describedherein have features which inhibit rotation between the distraction rod102, 302 and the monolithic member 104, 304, maintain the magnet 138,338 in its axial position in relation to the monolithic member 104, 304,and keep the distraction rod 102, 302 from falling out of the monolithicmember 104, 304 by providing a stopping mechanism at full extension. Allof these features were not achievable in prior devices without resortingto welds which decreased the overall strength.

While embodiments of the present invention have been shown anddescribed, various modifications may be made without departing from thescope of the present invention. For example, the magnets in the devicesmay be replaced by any type of drive member, for example motors or shapememory mechanisms. They may also be replaced by a subcutaneous leverthat allows the device to be non-invasively adjusted. The invention,therefore, should not be limited, except to the following claims, andtheir equivalents.

What is claimed is:
 1. A method of assembling a system for manipulatingportions of the skeletal system of a subject, the method comprising:obtaining a monolithic member having a first end and a second end, thefirst end configured for attachment to a first portion of the skeletalsystem and the second end comprising a housing having an axiallyextending cavity; obtaining a distraction rod having a first end and asecond end, the first end having an inner threaded cavity extendingalong at least a portion of a length thereof, the first end configuredto be coaxial and movable within the axially extending cavity and thesecond end configured to extend from the axially extending cavity andconfigured for attachment to a second portion of the skeletal system;rotationally coupling a rotatable, radially poled magnet to a lead screwhaving threads such that rotation of the magnet causes rotation of thelead screw; engaging the threads of the lead screw with the threadedcavity of the distraction rod; inserting the magnet and at least aportion of the first end of the distraction rod into the axiallyextending cavity such that the distraction rod and the monolithic memberare in coaxial relation to one another; axially locking the magnet inrelation to the monolithic member, wherein the axially locked magnet iscapable of rotation; and rotationally locking the distraction rod inrelation to the monolithic member.
 2. The method of claim 1, wherein therotationally locking operation further includes limiting axial movementof the distraction rod in relation to the monolithic member.
 3. Themethod of claim 1, wherein one full rotation of the magnet causes onefull rotation of the lead screw.
 4. The method of claim 1, furthercomprising the operation of forming a dynamic seal located between thedistraction rod and the monolithic member, the dynamic seal configuredto inhibit body fluids from entering the axially extending cavity. 5.The method of claim 1, further comprising the operation of placing ananti-rotation member in proximity with the monolithic member, theanti-rotation member configured to limit relative rotation between themonolithic member and the distraction rod, while allowing relative axialmovement between the monolithic member and the distraction rod.
 6. Themethod of claim 5, wherein the anti-rotation member is furtherconfigured to stop the relative axial movement between the monolithicmember and the distraction rod at or near a maximum extension of thedistraction rod.
 7. The method of claim 6, wherein the distraction rodcomprises at least one axially extending groove and wherein theanti-rotation member comprises at least one protrusion configured toextend into the groove.
 8. The method of claim 1, further comprising theoperation of forming one or more landmarks on at least a portion of thedistraction rod, the one or more landmarks configured for scatteringultrasound.
 9. The method of claim 8, wherein the one or more landmarkscomprise one or more holes located at a surface of the distraction rod.10. The method of claim 8, wherein the one or more landmarks comprise araised ridge extending around the distraction rod.
 11. A method ofassembling a system for manipulating portions of the skeletal system ofa subject, the method comprising: obtaining a monolithic member having afirst end and a second end, the first end configured for attachment to afirst portion of the skeletal system and the second end comprising ahousing having an axially extending cavity; obtaining a distraction rodhaving a first end and a second end, the first end having an innerthreaded cavity extending along at least a portion of a length thereof,the first end configured to be coaxial and movable within the axiallyextending cavity and the second end configured to extend from theaxially extending cavity and configured for attachment to a secondportion of the skeletal system; securing a maintenance member to themonolithic member, the maintenance member configured to magneticallyattract at least one pole of a rotatable, radially poled magnet;rotationally coupling the rotatable, radially poled magnet to a leadscrew having male threads such that rotation of the magnet causesrotation of the lead screw; engaging the threads of the lead screw withthe threaded cavity of the distraction rod; inserting the magnet and atleast a portion of the first end of the distraction rod into the axiallyextending cavity such that the distraction rod and the monolithic memberare in coaxial relation to one another; and axially locking the magnetin relation to the monolithic member, wherein the axially locked magnetis capable of rotation.
 12. The method of claim 11, further comprisingthe operation of rotationally locking the distraction rod in relation tothe monolithic member.
 13. The method of claim 12, wherein therotationally locking operation further includes limiting axial movementof the distraction rod in relation to the monolithic member.
 14. Themethod of claim 11, wherein one full rotation of the magnet causes onefull rotation of the lead screw.
 15. The method of claim 11, furthercomprising the operation of forming a dynamic seal located between thedistraction rod and the monolithic member, the dynamic seal configuredto inhibit body fluids from entering the axially extending cavity. 16.The method of claim 11, further comprising the operation of placing ananti-rotation member in proximity with the monolithic member, theanti-rotation member configured to limit relative rotation between themonolithic member and the distraction rod, while allowing relative axialmovement between the monolithic member and the distraction rod.
 17. Themethod of claim 16, wherein the anti-rotation member is furtherconfigured to stop the relative axial movement between the monolithicmember and the distraction rod at or near a maximum extension of thedistraction rod.
 18. The method of claim 17, wherein the distraction rodcomprises at least one axially extending groove and wherein theanti-rotation member comprises at least one protrusion configured toextend into the groove.
 19. The method of claim 11, wherein themaintenance member comprises 400 series stainless steel.
 20. The methodof claim 11, wherein the axially locking step utilizes inductionheating.